医用电气设备.第2-62部分:高强度治疗性超声(HITU)设备的基本安全性和必要性能的详细要求

[中文适用范围]： 本国际标准适用于 201.3.218@ 中定义的高强度治疗超声设备的基本安全和基本性能，以下简称 ME 设备。本国际标准添加或替换了 IEC 60601-1 中列出的专门针对高强度治疗超声设备的条款。如果某条款或子条款专门旨在仅适用于 ME 设备@或仅适用于 ME 系统@，则该条款或子条款的标题和内容将如此说明。如果情况并非如此@，则该条款或子条款同时适用于 ME 设备和相关的 ME 系统@。除通用标准 7.2.13 和 8.4.1 之外，本标准中的具体要求不涵盖本标准范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。注 1：另见通用标准 4.2。注 2：@在 HITU 场中@由于非线性传播效应，声波波形预计会极度失真@超声波测量将在准线性条件下进行，然后按照 IEC/TS 62556 中给出的程序进行推断。另请参见IEC/TS 61949 该标准还可适用于： 通过暴露于高强度治疗超声进行溶栓的治疗设备； ?C 治疗设备，用于通过暴露于高强度聚焦超声来治疗喂养血管闭塞； ?C 设备旨在用于缓解骨转移引起的癌症疼痛。该特定标准不适用于： ?用于物理治疗的超声波设备（使用：IEC 60601-2-5 [1]2）和 IEC 61689）； ？用于碎石术的超声设备（使用：IEC 60601-2-36 [2]）； ？用于专用热疗装置的超声波设备； ？用于超声乳化手术的超声设备。 2) 方括号内的数字指的是参考书目。 [外文原描述]： IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to - therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound; - therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound; - and equipment intended to be used for relieving cancer pain due to bone metastases. This particular standard does not apply to - Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689); - Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36); - Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and - Ultrasound Equipment intended to be used for phacoemulsification.